YM BioSciences's European partner Oncoscience has withdrawn its EMEA application for marketing authorization of nimotuzumab, an oncology drug already approved in 12 countries. In its official letter Oncoscience states that the withdrawal of the application was made 'because it was not able to adequately address the concerns of the CHMP regarding the quality and efficacy of the medicine within the required time schedule.' YM stressed that the delay was not due to questions about the treatment's overall efficacy, but the drug's effect in one subgroup of patients. The companies plan to re-submit at a later date.
- see YM's release